Yeda Res. and Dev. v. Mylan – “We don’t need no Stinkin’ Prior Art”

Friday, October 19, 2018

The quote is from “Treasure of the Sierra Madre” when a bandido leader is trying to convince Bogart that his gang are Federales, and Bogie asks to see their badges. In the context of Yeda Res. and Dev. v. Mylan, Appeal no. 2017-1594 et al. (Fed. Cir., October 12, 2018), it summarizes the Fed. Cir. panel’s difficulties in explaining its affirmance of the PTAB decision invalidating Yeda’s patents on a regimen for the administration of Copaxone. I am not going to comment on the merits of the obviousness rejection on appeal here, except to note that there was a lot of prior art in this area and some of it was close to the claimed regimen, which recited, essentially, administering six 40 mg doses over two weeks.

The prior art wasn’t the problem faced by the panel but, rather, that two publications were cited by Mylan’s expert and relied upon to some extent by the district court to support the obviousness rejection. These publications appeared after the filing date of Yeda’s patents and were not prior art under any section of 102. Yeda “cried foul”, arguing that the PTAB violated s. 311(b) by relying on these non-prior art publications.

The panel began by finding that non-prior art publications could still be “supporting evidence” under s. 312(a)(3). The panel framed the question as:

“whether the Board may consider non-prior art evidence…in considering the knowledge, motivations and expectations of a POSITA regarding the prior art….The Board has recognized that non-prior art evidence of what was known ‘cannot by applied independently, as teachings separately combinable’ with other prior art but ‘can be relied on for their proper supporting roles, e.g., indicating the level of ordinary skill in the art, what certain terms mean to [POSA] and how one of ordinary skill in the art would have understood the prior art disclosure. (citing Dominion Dealer Sols., LLC v. Autoalert, Inc. IPR 2014-00684 (PTAB Oct. 6, 2014).’”

To begin with, it is odd that the panel cited a Board decision as authority as to the proper use of information acquired after the effective filing date of a patent. There is lots of Fed. Cir. case law on this topic, and much of it is cited in MPEP 2124 – “Exception to the Rule That the Critical Reference Date must Precede the Filing Date.” I won’t try to summarize it here, but all of the case law appears to relate to issues of claim construction and not to the ultimate issues as set forth in s. 112. In fact, MPEP 2124 flatly states that “it is impermissible to use a later factual reference to determine whether the application is enabled or described as required [by s. 112, first para.] (citing In re Koller, 613 F.2d 819 (CCPA 1980)).

But, try as I might, I could not find a case clearly stating that later-publications could not be used to “support” an obviousness rejection, although the Board in Dominion comes close, since the question in that case turned on an obviousness determination. However, the panel in Yeda appeared to endorse the use of the results of a clinical trial that were not prior art to the claimed regimen as evidence that the POSA would be motivated to alter the primary prior art reference so as to arrive at the claimed regimen:

“In this regard [ed. applied in its proper supporting role], Dr. Green’s reliance on [a non-prior art publication] is permissible, as it supports and explains his position that a POSITA would have thought less frequent dosing [the invention] worthy of investigation as of the priority date…[quoting the Board] ‘[The non-prior art publication] is probative of the fact that those skilled in the art were motivated to investigate dosing regimens of [the drug] with fewer injections, to improve patient compliance.’”

Remarkably, while endorsing this supporting role for non-prior art publications, the panel found that the Board’s reliance on the non-prior art publications to reach a conclusion of reasonable expectation of success was harmless error. Of course, a finding of motivation to alter the prior art invention and a reasonable expectation of success are pillars of an obviousness rejection. In fact, citing the KSR standards of obviousness, the panel concluded: “The prior art disclosed both daily and every other day administration, and the Board found a motivation for both less frequent injections and a thrice-weekly regimen specifically.”

If you have read this far, the policy behind severely limiting the use of post filing date publications should be coming in to view. The MPEP does not articulate it, but one of the most-cited decisions in this area does – In re Hogan, 559 F.2d 595 (CCPA 1977) does. As you read this quotation, imagine that in this case, that the non-prior art regimen represented a patentable advance over the Yeda regimen:

“The use of a subsequently-existing improvement [e.g., the non-prior art publication] to show lack of enablement in an earlier filed application on the basic invention [Yeda’s claimed invention] would preclude issuance of a patent to the inventor of the thing improved, and in the case of issued patents, would invalidate all claims…therein. Patents are and should be granted to later inventors upon unobvious improvements. Indeed, encouragement of improvements on prior inventions is a major contribution of the patent system and the vast majority of patents are issued on improvements. It is quite another thing, however, to utilize the patenting or publication of later existing improvements to ‘reach back’ and preclude or invalidate a patent on the underlying invention.” Hogan, 559 F.2d at 606. See J.M. Mueller, Patent Law (5th ed., 2016) at pages 222-224.

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